CompletedNot Applicable

Pain and Comfort Level During Orogastric Catheter Insertion in Preterms

Turkey (Türkiye)60 participantsStarted 2022-03-01

Plain-language summary

Purpose of the research: This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit. Hypotheses: H0: The methods used during orogastric tube insertion do not affect the pain and comfort levels of preterm babies. H1: Preterm babies who are breastfed feel less pain during orogastric tube insertion. H2: Preterm babies given dextrose during orogastric tube insertion feel less pain. H3: The comfort level of preterm babies who are breastfed during orogastric tube insertion is higher. H4: The comfort level of preterm babies given dextrose during orogastric tube insertion is higher. H5: There is a difference between the pain and comfort levels of preterm patients in terms of group, time, and group-time, depending on the intervention applied.

Who can participate

Age range

32 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Birth week 32-34, * Postnatal week has reached 32-34 weeks, * Birth weight over 1500 grams, * whose general condition is stable, * Planned to insert an orogastric tube, * Developed sucking and swallowing reflexes, being able to hold a pacifier, * Having breast milk, * Preterms whose parents agreed to participate in the study were included in the study. Exclusion Criteria: * In need of oxygen support, * Receiving analgesic and/or sedation treatment, * In the preoperative and/or postoperative period, * Those with congenital anomalies of the mouth and palate, * Those with metabolic (e.g. NEC) and genetic (e.g. osteogenesis imperfecta) diseases, * Painful intervention was performed at least 30 minutes before the procedure, Preterm babies will be excluded from the research.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

OG catheter-related pain

Timeframe: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion

OG catheter-related comfort

Timeframe: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion

Trial details

NCT IDNCT06222047

SponsorDokuz Eylul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

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